EU GMP Annex 1 webinar series

For aseptic processing the requirements of Annex 1 are clear – continuous monitoring. However, what about support rooms and the other areas of the facility where a product is made? How should monitoring frequencies for non-sterile areas be approached?

In this webinar, we consider:

•    Risk based approaches to environmental monitoring 
•    The key factors that influence monitoring frequencies
•    How to set a risk based approach for monitoring frequencies
•    How to applying risk based methods to reduce the number of samples taken within a room
•    How things can go wrong and what makes for a poor risk assessment

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Designing a contamination control strategy is central to the revision to EU GMP Annex 1. But how should this be approached? During this webinar, we explore the elements you need to consider when building a contamination control strategy. This includes designing a strategy that is holistic, interlined, and relevant.

A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring (detectability of contamination event). This webinar presents the fundamentals of such a strategy.

Topic areas we cover include:

• Microbial contamination
• Cleaning and disinfection
• Sterility assurance
• Facility design
• Chemical and particle contamination
• Other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations

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The environment in which products are processed or within which the sterility test is conducted must be designed in such a way that the risk of contamination is minimised. The environment is designed to prevent cross-contamination, from the environment or from the operator, from occurring. The isolator provides the optimal means to achieve this.

However, poorly designed and maintained isolators can themselves be sources of contamination, arising from poorly executed decontamination cycles to leaks from gauntlets.

Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when designing, qualifying and operating isolators.

Topic areas we cover include:

• Isolator design and testing
• Air and particulate control
• Developing the best qualification approach
• Fragility of vapour disinfection of isolators
• Prerequisite tests for effective isolator operation
• Vulnerability of isolator gloves and gauntlets
• Qualifying isolators with chemical and biological indicators
• Troubleshooting isolator operational problems

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The revision to EU GMP Annex 1 calls for an environmental monitoring programme that is proactive, and risk based. The use of a simple ‘one size fits all’ approach to monitoring is no longer relevant.

This includes addressing issues like pre- and post-shutdown assessments of facility environments; selecting monitoring locations by risk assessment; addressing concerns with cleaning and disinfection; and adapting programmes for ageing facilities.

Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when fine tuning the environmental monitoring programme.

Topic areas we cover include:

• Contamination sources and vectors of contamination
• Linking environmental monitoring to change control
• Introducing risk based thinking to environmental monitoring sample selection and frequency determinations
• Going beyond the standards
• Linking monitoring to cleaning and disinfection
• Using rapid microbiological methods appropriately
• Connecting monitoring to facility maintenance
• Linking monitoring to shutdowns
• Tracking and trending microorganisms
• Setting appropriate limits

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To avoid cross-contamination between different products and to remove residues and microorganisms, cleaning validation plays a central part in any pharmaceutical facility’s contamination control programme.

An effective approach to cleaning validation will be risk-based. A cleaning process has to be considered as any other process, for which critical process parameters have to be defined.

Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when putting together a cleaning validation strategy. 

Topic areas we cover include:

• Critical Process Parameters (CPPs) for cleaning
• Critical Quality Attributes (CQAs) for cleaning
• Pre-requisites to begin cleaning validation
• Introducing risk-based thinking into the cleaning validation process
• Product and material groupings
• Assessing hold times
• Microbial attachment and removal
• Selecting optimal analytical test methods
• Why cleaning validation fails

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Single use sterile disposable technologies have great advantages in reducing turnaround times and the drain on plant utilities, as well as improving sterility assurance. However, such technologies also introduce potential risks.

In this webinar we focus on how to select and evaluate different technologies from a vendor, considering:

•    Different sterilisation technologies
•    How to assess shelf-life and what can go wrong, from discolouration to embrittlement
•    How to ensure a sterile path - microbial immersion studies
•    The risk of introducing toxic substances into the product - addressing through the use of leachable and extractables testing
•    Vendor approval, management and the change control process

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Disinfectant efficacy assessments are given greater prominence in the updated EU GMP Annex 1. Yet there are competing standards and different expectations for vendors and users.

Cleaning and disinfection are essential for maintaining facility control. For the user, there are choices to be made between different agents, with application techniques, assessing biocidal efficacy, and addressing residues. Approaching these issues in the wrong way can be time consuming and expensive. This webinar offers a road map towards disinfection compliance.

Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when designing a disinfectant efficacy programme. 

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Water is fundamental to pharmaceutical manufacturing yet a poorly designed or maintained water system can become the source of chemical or microbial contamination. Since water is ever present, each grade of water can present a contamination risk.

Microbial contamination includes overall bioburden, the problems posed by specific species, and with the release of endotoxin. 

Microbiologist and sterility expert Dr Tim Sandle joins RSSL Sterile Manufacture Lead Annette Russell to explore the elements you need to consider when addressing water system contamination issues, including addressing problems through repair, use of chemicals and heat.

Topic areas we cover include:

•    Risks of microbial contamination
•    Biofilms
•    Good design issues – from flow rates to deadleg avoidance
•    Avoiding problems when water systems go off-line
•    Addressing contamination problems
•    Monitoring and trending
•    Learning points

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Identifying microbes plays a key role in Environmental Monitoring, enabling processes to evolve and improve. Getting a good identification programme in place with the right technologies is the smart move. In our latest Annex 1 webinar Microbiology expert Dr Tim Sandle explores this issue, giving you the basics on getting your microbial programme into the best shape.

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Hosted by Dr Tim Sandle, this webinar covers the new EU GMP Annex 1, looking at the key messages and areas that need to be focused on to deliver product and patient safety.

We will delve into the aspects that all manufacturers need to consider to remain compliant, including quality risk management, contamination strategy, cleanroom certification and water systems.

Learning outcomes:

• Understand the major updates to EU GMP Annex 1 and how they differ to the current guidance
• Learn how the key changes will impact the control and release of sterile products
• Gain an insight into the elements required for a contamination control strategy
• Become familiar with the importance of quality risk management in relation to sterile products
• Consider those areas that regulators are likely to put the greatest emphasis upon

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Quality risk management is a core requirement of the Annex 1 revision, with regulators nudging the industry towards adopting a proactive approach to risk assessment. This webinar considers the appropriate areas to assess, including in relation to contamination control and sterility assurance.

Learning outcomes: 

Understand the fundamentals of risk management
- Discover the tools and techniques for risk management
-  Appreciate the importance of a scientific and data driven approach to risk management
- Gain insight through considering case studies in risk management
- Understand how risk management can go wrong

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A contamination control strategy is a system that considers all the integral elements of pharmaceutical product manufacturing. This is best achieved using quality risk management principles and supporting risk assessments for contamination control and monitoring (detectability of contamination event). This webinar presents the fundamentals of such a strategy.

Fundamentals covered: 

- Microbial contamination
- Cleaning and disinfection
- Sterility assurance
- Facility design
- Chemical and particle contamination
- Other forms of contamination that can arise from mix-ups, damaging primary or secondary packaging, distribution problems, and environmental fluctuations

The need for a contamination control strategy will be a core part of the revision to EU GMP Annex 1 and this webinar will provide advice on how to meet this requirement.

Watch on demand here

Learning Outcomes:

The difficulties associated with sterility test method validation in general
- Practical approaches for products where pharmacopoeial methods cannot be readily applied
- Some supporting aspects for sterility test method validation
- Essential validation documentation
- Guidance on training requirements

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There are different sources of microbial cleanroom contamination. However, the most common source is with people, both in terms of what is carried on the human body and how people behave. 

People risks include:

- Skin flakes and oil
- Cosmetics and perfume
- Spittle
- Clothing debris (lint, fibres etc.)
- Hair
- Touching and transfer
- Rapid movements

This webinar considers strategies to minimise people related contamination, including a review of gowning, gloves and masks, disinfection, behaviours and training.

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Learning Outcomes:

What environmental is and what it is not
- Understand the objectives of environmental monitoring as well as aspects to consider with EM methods
- Understand contamination sources and risks and how to profile microbial contamination
- Rapid microbiological methods
- Core elements of the EM programme – what, when and how often?
- Data and CAPA

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Spores, both bacterial and fungal, present problems for contamination control. Spores are very resistant to conventional cleaning and disinfection, with bacterial spores presenting a resistance problem and fungal spores presenting a particular risk in terms of dispersal. 

Learning outcomes:

Overview of spores
        - Bacterial
        - Fungal
- Risks posed by spores to pharmaceutical operations
- Sporicidal disinfectants: Selection and concerns
- Issue of disinfectant / sporicide resistance
- Sources of spores

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The need to identify and characterise unknown impurities in pharmaceutical products is of paramount importance. Characterisation is required to allow for toxicological assessment of degradation products and allows greater understanding of degradation pathways which may influence the efficacy of the treatment. 

A wide range of analytical techniques may be called upon during characterisation studies, depending on the nature and size of the impurity molecule, the complexity of the formulation matrix and the level at which the impurity is observed.  

This webinar will take a deep dive into nuclear magnetic resonance (NMR) spectroscopy and accurate mass liquid chromatography mass spectrometry (LC-MS) to leverage knowledge in the assessment and characterisation of this industry critical scientific challenge.

Learning outcomes:

•    Understanding impurities - contamination in a nutshell
•    Recognising the scientific necessity and regulatory requirements
•    Appreciating the analytical tools typically used, including their advantages and limitations 
•    Understanding the approach to characterising impurities with attention given to LC-MS and NMR. Examples using these methods will be shared to 
        demonstrate this 

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